Lay Health Worker Engage, Educate, and Encourage Patients to Share (LEAPS)

The purpose of the LEAPS program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and healthcare resource utilization.

Study Overview

• Status: Completed
• Conditions: Cancer; End of Life
• Intervention / Treatment: Behavioral: Lay Health Worker Intervention; Other: Usual Care

Detailed Description

Unite Here Health proposes to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their members. The Lay Health Worker Engages, Educates, and Encourages Patients to Share intervention is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Unite Here Health members who are diagnosed with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals. The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation and quality of life outcomes, and that the program helps to reduce utilization of health care resources at the end of life.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Newly diagnosed patients with a cancer diagnosis.
2. Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
3. The patients must be 18 years or older.
4. Patients must have the capacity to verbally consent.

Exclusion Criteria:

1. Inability to consent to the study due to lack of capacity as documented by the referring physician.
2. Patients without a newly diagnosed malignancy or patients without relapse of disease.
3. Patients not eligible for Fund benefits.

Patients without a newly diagnosed malignancy or patients without relapse of disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group Arm; Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice). The intervention arm will also receive usual care as provided by Unite Here Health and their local oncologists.	Behavioral: Lay Health Worker Intervention; Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice). The intervention is provided along with usual care as provided by Unite Here Health and local oncologists.; Other: Usual Care; Usual care as provided by Unite Here Health and local oncologists
Active Comparator: Control Group Arm; The control group arm will receive usual care as provided by Unite Here Health and their local oncologists.	Other: Usual Care; Usual care as provided by Unite Here Health and local oncologists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey	Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at baseline and 4 months. We will measure the change in quality of life at baseline to 4 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life.	Change in Quality of Life from Baseline to 4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department Visit (Chart Review)	Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Emergency Department Visit (Chart Review)	Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Hospitalization Visit (Chart Review)	Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Hospitalization Visits (Chart Review)	Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after study enrollment
Hospitalization Visits (Chart Review)	Hospitalization use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their hospital visits during the last 30 days of life.	last 30 days of life
Advance Directive Documentation (Chart Review)	Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Advance Directive Documentation (Chart Review)	Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Physician Orders for Life Sustaining Treatment (Chart Review)	Physician Orders for Life Sustaining Treatment (POLST) documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Physician Orders for Life Sustaining Treatment (Chart Review)	Physician Orders for Life Sustaining Treatment (POLST) documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Goals of Care Documentation (Chart Review)	Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Goals of Care Documentation (Chart Review)	Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Total Costs of Care	Total Costs of Care will be evaluated by review of claims data from time of enrollment until 12 months post-enrollment	12 months after patient enrollment
Palliative Care Use (Chart Review)	Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Palliative Care Use (Chart Review)	Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Palliative Care Use (Chart Review)	Palliative Care Use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their palliative care usage during the last 30 days of life.	last 30 days of life
Hospice Use (Chart Review)	Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Hospice Use (Chart Review)	Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Hospice Use (Chart Review)	Hospice Use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their hospice use during the last 30 days of life.	last 30 days of life
Survival (Chart Review)	Survival rate for patients will be abstracted by electronic medical record chart review at 4 months after enrollment.	4 months after patient enrollment
Survival (Chart Review)	Survival rate for patients will be abstracted by electronic medical record chart review at 12 months after enrollment.	12 months after patient enrollment
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey	The validated Satisfaction with Decision (SWD) Survey was administered to all participants at 4 months after study enrollment. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. "I am satisfied that I am adequately informed about the issues important to my decision") on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Scores for each group were averaged at 4 months after study enrollment. Results are expressed as a proportion of participants who responded "strongly agree" at 4 months post-enrollment on the SWD scale, which measured ratings of decision-making. Changes in the proportion of participants who responded "strongly agree" are reflected from baseline to 4 months post-enrollment.	Proportion of patients who strongly agree that decisions about their health care were theirs to make at 4 months post study enrollment.
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey	The validated Satisfaction with Decision (SWD) Survey was administered to all participants at 12 months after study enrollment. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. "I am satisfied that I am adequately informed about the issues important to my decision") on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Scores for each group are averaged at 12 months after study enrollment. Results are expressed as a proportion of participants who responded "strongly agree" at 12 months post-enrollment on the SWD scale, which measured ratings of decision-making. Changes in the proportion of participants who responded "strongly agree" are reflected from baseline to 12 months.	Proportion of patients who strongly agree that decisions about their health care were theirs to make at 12 months post study enrollment.
Patient Activation Using the Patient Activation Measure Survey	Each patient will receive the 13-item Patient Activation Measure (PAM-13) at 4 months after study enrollment. This is a validated measure from Insignia Health. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. For the PAM-13, minimum score is 0 and maximum is 100. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining Behaviors and Pushing Further. Scores for each group will be averaged at 4 months after study enrollment.	Change in Patient Activation Measure from baseline to 4 months post enrollment.
Patient Activation Using the Patient Activation Measure Survey	Each patient will receive the 13-item Patient Activation Measure (PAM-13) at 12 months after study enrollment. This is a validated measure from Insignia Health. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. For the PAM-13, minimum score is 0 and maximum is 100 (highest level of activation). Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining Behaviors and Pushing Further. Scores for each group will be averaged 12 months after study enrollment.	Change in Patient Activation Measure from baseline to 12 months post-enrollment.
Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey	Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at 12 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General Survey-General survey. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life.	Health-related quality of life at 12 months
Emergency Department Visit (Chart Review)	Emergency Department Use will be abstracted by electronic medical record chart review for each patient who is deceased within 12 months of enrollment, looking at their ER visits during the last 30 days of life.	Last 30 days of life up to 12 months from patient enrollment
Total Costs of Care End of Life	Total Costs of Care during the last 30 days of life will be evaluated by review of claims data from the 30 days preceding death for those patients who become deceased within 12 months of study enrollment.	Last 30 days of life up to 12 months from patient enrollment
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey	The validated Satisfaction with Decision (SWD) Survey was administered to all participants at baseline. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. "I am satisfied that I am adequately informed about the issues important to my decision") on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Results are expressed as a proportion of participants who responded "strongly agree" at Baseline on the Satisfaction with Decision scale, which measured ratings of decision-making.	Proportion of patients who strongly agreed the decisions about their health care were theirs to make at baseline (study enrollment).

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Manali I Patel, MD MPH MS, Stanford University

Publications and helpful links

General Publications

• Patel MI, Khateeb S, Coker T. A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings. Contemp Clin Trials. 2020 Apr;91:105971. doi: 10.1016/j.cct.2020.105971. Epub 2020 Mar 4.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cancer; end of life; patient-centered
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: 40447; K23MD013474-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No